An interventional study of Adhesiolysis in Low Back Pain, sponsored by Pain Management Center of Paducah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Pain Management Center of Paducah · Not applicable, Interventional, and Treatment
To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
To evaluate and compare the adverse event profile in all groups.
Recruitment is indicated in patients with chronic low back pain and lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States.
The study involves 240 patients studied in 4 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.
Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value \< 0.05.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 240 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Pain Management Center of Paducah is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria:
Exclusion criteria:
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Procedure: Adhesiolysis
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
Procedure: Adhesiolysis
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;
Procedure: Adhesiolysis
Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
Procedure: Adhesiolysis
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Also known as: Adhesiolysis in post-surgery
Numeric rating scale (NRS), Oswestry Disability Index (ODI),
duration of significant pain relief, opioid intake, and return to work
Time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
Adverse event profile of side effects and complications.
Record side effects and any complications
Time frame: Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pain Management Center of Paducah